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NICE cites lack of evidence for ‘promising’ sepsis tests

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There is not enough evidence to currently recommend the routine use of promising new tests to help identify cause of sepsis, according to the National Institute for Health and Care Excellence.

In final diagnostics guidance, NICE recommended that further research be carried out on three new blood tests for speeding up the identification of bloodstream bacteria and fungi in patients with suspected bloodstream infections.

“There was currently too much uncertainty in their accuracy”

Carole Longson

The three tests in question are the LightCycler SeptiFast Test MGRADE, manufactured by Roche Diagnostics, the SepsiTest, made by Molzym Molecular Diagnostics, and Abbott Laboratories’ IRIDICA BAC BSI assay.

The tests analyse whole blood samples to identify bacterial and fungal DNA, with the aim of identifying the causes of infection much quicker than traditional microbiology techniques that require blood samples to be incubated and cultured before pathogens can be identified.

Rapidly detecting bacterial and fungal DNA may reduce the length of time broad spectrum antibiotics and antifungals are used and allow targeted treatment earlier in the care pathway.

Professor Carole Longson, director of the NICE Health Technology Evaluation Centre, highlighted that tests that could identify the cause of infection in hours rather than the days needed for traditional microbiology tests could “ensure the most appropriate antibiotics are used much earlier”.

Professor Carole Longson

Professor Carole Longson

Carole Longson

But she noted that NICE’s independent diagnostics advisory committee had concluded that, although the new tests showed promise, there was currently not enough evidence to recommend their routine adoption in the NHS.

“There was currently too much uncertainty in their accuracy for clinicians to be able to use them as the basis for clinical decision-making in people with suspected bloodstream infections, who can be acutely unwell,” she said.

She added: “Further research should be encouraged to provide robust evidence, particularly around demonstrating the value of using the test results in clinical decision-making.”

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